CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 76 enrolled
Drug / intervention
Erlotinib +1 moredrug
Likely dose
Erlotinib 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00977470
NCT00977470Phase 2Active

Phase II Study of Erlotinib With or Without Hydroxychloroquine in Patients With Previously Untreated Advanced NSCLC and EGFR Mutations

Massachusetts General Hospital·interventional·Posted Sep 15, 2009·Updated Oct 15, 2025

In Brief

A Phase 2 clinical trial evaluating Erlotinib and Hydroxychloroquine for Non-small Cell Lung Cancer. Active but no longer recruiting, targeting 76 participants across 4 sites.

Detailed Summary

The purpose of this research study is to learn if adding hydroxychloroquine (HCQ) to erlotinib helps treat non-small cell lung cancer (NSCLC). Another goal of this research study is to learn more about NSCLC and how it may respond to study treatment. Erlotinib (Tarceva) is a type of drug called a tyrosine kinase inhibitor (TKI). TKIs block a protein called the epidermal growth factor receptor (EGFR). EGFR may control tumor growth and tumor cell survival. However, although TKI drugs can work for some lung cancer patients for a period of time, eventually the tumor finds a way to resist or counteract the TKI treatment and it begins to grow again. Hydroxychloroquine (HCQ) is a drug approved by the FDA for treating malaria, rheumatoid arthritis, and several other diseases. Laboratory research suggests that when HCQ is given with a TKI, it may help delay or prevent TKI resistance from developing.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2Active
2010201120122013201420152016201720182019202020212022202320242025202620272028
First PostedSep 15, 2009
Enrollment StartOct 1, 2009
Primary CompletionMay 1, 2015
Study CompletionDec 1, 2027
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 16.8 years ago

Interventions

Erlotinibdrug

150 mg taken orally once daily

Hydroxychloroquinedrug

1000 mg taken orally once daily after erlotinib